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RSS FeedPosted by Michael Wonder on 25 Feb 2025
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus standard of care as peri-operative treatment for resectable locally advanced head and neck squamous cell carcinoma
25 February 2025 - Acceptance based on results from the KEYNOTE-689 trial: the first Phase 3 trial to demonstrate significant improvement ...
Posted by Michael Wonder on 25 Feb 2025
Glaukos announces FDA acceptance of NDA submission for Epioxa
24 February 2025 - PDUFA date set for 20 October 2025. ...
Posted by Michael Wonder on 24 Feb 2025
US FDA grants fast track designation to Coherent Biopharma’s CBP-1019
21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...
Posted by Michael Wonder on 24 Feb 2025
Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia
24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...
Posted by Michael Wonder on 24 Feb 2025
US FDA accepts BMS’s supplemental biologics license application for Opdivo plus Yervoy for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
24 February 2025 - Application based on analyses from the Phase 3 CheckMate-8HW clinical trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 23 Feb 2025
Luxa Biotechnology announces FDA regenerative medicine advanced therapy designation granted to RPESC-RPE-4W transplantation for the treatment of dry age-related macular degeneration
19 February 2025 - Luxa Biotechnology today announced that the US FDA has granted regenerative medicine advanced therapy designation to RPESC-RPE-4W ...
Posted by Michael Wonder on 21 Feb 2025
Alvotech and Teva announce filing acceptance of US biologics license application for AVT06, a proposed biosimilar to Eylea (aflibercept)
18 February 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review a biologics license ...
Posted by Michael Wonder on 21 Feb 2025
FDA approves first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disease
21 February 2025 - Today, the US FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis in adults. ...
Posted by Michael Wonder on 20 Feb 2025
PolarityBio receives US FDA breakthrough therapy designation for treatment of Wagner grade I diabetic foot ulcers
20 February 2025 - The FDA has granted breakthrough therapy designation for SkinTE based on key positive data from the Phase ...
Posted by Michael Wonder on 20 Feb 2025
BioRestorative receives FDA fast track designation for BRTX-100 chronic lumbar disc disease program
20 February 2025 - Reflects positive preliminary Phase 2 safety and efficacy data reported to date. ...
Posted by Michael Wonder on 20 Feb 2025
World’s first potential target therapy for diffuse gastric cancer granted fast track designation by the US FDA
20 February 2025 - Signet Therapeutics announced that the US FDA has granted fast track designation for SIGX1094, the world's first ...
Posted by Michael Wonder on 20 Feb 2025
AskBio receives FDA regenerative medicine advanced therapy designation for Parkinson’s disease investigational gene therapy
19 February 2025 - Regenerative medicine advanced therapy designation follows Phase Ib 36 month data. ...
Posted by Michael Wonder on 20 Feb 2025
Harmony Biosciences provides update on the status of the supplemental new drug application for pitolisant in idiopathic hypersomnia
19 February 2025 - Harmony Biosciences today announced that it received a refusal to file letter from the US FDA for ...
Posted by Michael Wonder on 20 Feb 2025
Doron Therapeutics receives FDA regenerative medicine advanced therapy designation for Motys for treatment of symptoms associated with osteoarthritis
19 February 2025 - Doron Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 20 Feb 2025
PTC Therapeutics announces FDA acceptance and priority review for vatiquinone NDA for the treatment of children and adults with Friedreich's ataxia
19 February 2025 - PDUFA target action date of 19 August 2025. ...